Clinical Laboratory / CLIA
42 CFR Part 493. CAP. COLA. One platform, every compliance control.
Built for CLIA-certified labs running moderate and high complexity testing. Often called an LIS (Laboratory Information System) in clinical settings, AILS manages the full specimen lifecycle — every QC review, proficiency testing cycle, personnel qualification, and corrective action under 42 CFR 493 governance with tamper-evident documentation.
Built for Clinical Laboratory / CLIA
Every capability is purpose-built for your compliance environment — not adapted from a generic platform.
CLIA Self-Audit
AI-powered self-audit scores your lab against 42 CFR 493 subparts — from QC (§493.1256) to personnel (§493.1405) to proficiency testing (§493.801). Downloadable audit report for your CAP/COLA inspector.
QC Management
Per-run QC logging with z-score computation and Westgard 1-3s / 1-2s violation detection. Every out-of-control event auto-creates a linked deviation for corrective action and re-verification before patient result release.
Proficiency Testing Tracking
Log PT results, track enrollments, and auto-trigger CAPAs on PT failures. AILS documents the investigation and corrective action required under §493.841.
Personnel Qualifications
Track CLIA-required qualifications, initial competency assessments, and ongoing competency evaluations. Hard block on testing procedures when competency is overdue.
Chain of Custody + Result Reporting
Full specimen lifecycle from intake to result. Tamper-Evident COAs for final patient reports — SHA-256 locked, no post-issue edits by anyone.
SOPs + Training Gates
CLIA-compliant procedure manual with mandatory training sign-off. API-enforced training gates — expired training blocks the five signing and issuing actions, not warns.
Purpose-built agents for Clinical Laboratory / CLIA
Each agent operates on your live lab data, scoped to one specific job. Not a generic assistant.
CLIA Self-Audit Agent
Assesses your lab against all applicable 42 CFR 493 subparts. Generates a scored readiness report with finding severity classifications and recommended corrective actions.
COA AI Quality Checker
Scans every issued result report against your method specifications. Flags outliers, reference range deviations, and delta check failures before results reach clinicians.
SOP AI Generator
Drafts CLIA-compliant procedure sections referencing 42 CFR 493 requirements and CLSI guidelines applicable to your test menu.
Enabled at tenant provisioning.
One platform. Your vertical. Ready today.
The Clinical Laboratory workflows, compliance frameworks and AI agents ship today — built, tested, and covered by the platform test suite. Configuration, not architectural change, is what stands between you and go-live.